- 13-week U.S. Phase II study is evaluating the efficacy, safety and tolerability of oral small molecule GLP-1R agonist ASC30, a once-daily tablet, in 100 participants with diabetes.

- Topline data from the Phase II study are expected in the third quarter of 2026.

Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces completion of enrollment in its 13-week U.S. Phase II study (NCT07321678) evaluating ASC30, an oral small molecule GLP-1 receptor (GLP-1R) agonist, for the treatment of type 2 diabetes mellitus (T2D). T2D is the second indication for ASC30, following its first indication of obesity. Topline data from the Phase II study for the treatment of T2D are expected in the third quarter of 2026.

"ASC30 has potential to be the best-in-class oral small molecule GLP-1 for obesity, evidenced by its efficacy and tolerability demonstrated by the U.S. Phase II study in participants with obesity or overweight," said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, "Expanding ASC30's clinical development into the large diabetes treatment market is a logical next step that provides us with another chance to highlight ASC30's potential best-in-class profile as a once-daily oral treatment option for patients. We look forward to sharing topline data from the Phase II study in diabetes participants in the third quarter of 2026."

Dr. Wu added, "Based on the positive clinical results announced in December 2025 from our 13-week U.S. Phase II study of ASC30 in participants with obesity or overweight, the Company expects to obtain the clearance from the U.S. Food and Drug Administration and initiate Phase III trials in the U.S. for obesity indication by the end of the third quarter 2026."

ASC30 was discovered and developed in-house at Ascletis as a first and only investigational small molecule GLP-1R fully biased agonist that can be dosed once daily orally and once monthly to once quarterly subcutaneously for the treatment of obesity, diabetes and other metabolic diseases.